Filter News

Fractyl Labs Launches Pivotal Revita Diabetes Device Trial

Published: Jul 17, 2015

First Patients Enrolled in Multicenter Clinical Trial of Fractyl Revita DMR System

WALTHAM, Mass.--(BUSINESS WIRE)--Fractyl Laboratories Inc. (Fractyl) today announced that patient
enrollment has begun in a multicenter clinical trial (“Revita-1” trial)
being conducted in Europe and South America to evaluate the safety and
performance of the Revita™ Duodenal Mucosal Resurfacing™ (DMR) System.
Revita is the first non-invasive, implant free duodenal resurfacing
procedural therapy designed to directly treat the digestive causes of
insulin resistance in patients with uncontrolled type 2 diabetes.

“The Revita-1 study will expand our understanding of the safety and
efficacy of the Revita DMR procedure in patients with type 2 diabetes,”
said Harith Rajagopalan, MD, PhD, Co-Founder and CEO of Fractyl. “It
will also guide our plans for multi-arm pivotal trials, along with data
from our earlier, proof-of-concept human studies that we plan to publish
this year.”

More than ten patients have been treated in the first phase of the
Revita-1 study, which will enroll 50 patients across ten international
sites. The primary efficacy endpoint is change in HbA1c in patients with
uncontrolled type 2 diabetes, defined as having poor glucose control on
oral medications and an HbA1c of 7.5 to 10 percent. The second phase of
the study, a double-blinded, sham-controlled trial that will enroll up
to 240 patients, will begin in 2016.

“My center has now treated four patients in the Revita 1 trial, and two
patients have crossed the one-month threshold and appear to be well
satisfied with this minimally invasive procedure,” said Geltrude
Mingrone, MD, PhD. “We have known for some time that bariatric surgeries
can improve glycemic control independent of weight loss; it will be
interesting to see if Revita can offer a safe, less invasive option with
similar metabolic benefits.”

About Fractyl and the Revita™ Duodenal Mucosal Resurfacing (DMR)
System

Fractyl Laboratories Inc., a private company based in Waltham, MA, was
founded with the mission to change the treatment of type 2 diabetes.
Fractyl has developed a minimally invasive, device-based, implant-free
duodenal mucosal resurfacing procedure (Revita DMR) that directly
addresses the intestinal hormonal impairment that contributes to insulin
resistance and changes how the body absorbs and processes sugar. Fractyl
is currently engaged in clinical trials designed to demonstrate that the
Revita DMR procedure can dramatically improve glucose control and
potentially reduce the need for additional medications in type 2
diabetes. For more information, visit www.fractyl.com
or www.twitter.com/FractylLabs.